Editor’s note: Joe Plandowski’s understanding of and interest in in-office pathology laboratories is beyond dispute. We publish his letter, as always, to share his thoughts with readers of CAP TODAY. Here’s the take of CAP president Stanley Robboy, MD, on what follows: “Joe Plandowski and Kenneth Iczkowski, MD, author of the second letter, raise the issue of standard of care. The Mitchell study (Health Affairs, April 2012), however, was not designed to explore standard of care; rather, it examined billing practices and showed more biopsies and deteriorating rates of cancer detection when physicians had a financial interest in performing the biopsy and reporting its results. But what should be the standard of care is an important question deserving serious study. To answer it, studies must take into account detection rates of cancers requiring treatment, cost, and complications (quality of life), all judged against long-term outcomes.”

While CAP leaders hail the study by Jean Mitchell, PhD, on overutilization by urologists within their in-office pathology laboratories, perhaps they should ponder a few points along the way.

For starters, Dr. Robboy’s May 2012 column should have included an exemption for dermatologists when referring to “‘insourced’ biopsies, which cannot be processed, examined, and reported with a diagnosis while the patient is still in the office.” If not, I wonder what I was doing on two separate occasions while laid out in a dermatologist’s procedure room for MOHS surgery on my face while awaiting diagnosis on the part of my face that was now a tissue specimen. It seems appropriate to have dermatologists continue with their in-office tissue and MOHS pathology laboratories.

Dr. Robboy goes on to say “we needed objective evidence.” I couldn’t agree more. With that said, really objective evidence can be found in the most recent issue of the American Journal of Clinical Pathology (2012;137:739–746). The article, “Findings in 12-core transrectal ultrasound-guided prostate needle biopsy that predict more advanced cancer at prostatectomy” by Kryvenko, et al. of the Department of Pathology at Henry Ford Hospital, is very informative.

The authors say, “At our institution, most urologists currently use a 12-core transrectal ultrasound-guided prostate needle biopsy (TRUS) as the initial procedure for patients with an elevated serum PSA level and a digital rectal examination that fails to detect a ‘suspicious’ nodule(s).” They further go on to say, “This article presents a comprehensive analysis of the features of 12-core TRUS, the most widely used initial biopsy in contemporary practice, that predict locally advanced disease at radical prostatectomy when combined with the preoperative PSA level.” And, they continue with: “The needle cores were submitted separately and individually for each biopsy site.” Namely, 12 cores and 12 specimen vials.

The authors hit the key point when they say, “Compared with the correlation provided by sampling techniques that collected few samples, the sampling protocol used in this study, 12-core TRUS, allowed better correlation between the number and percentage of positive biopsy cores and pathologic tumor stage. A historical factor that confounds this comparison is the temporal sequence in which the 12-core TRUS was introduced after PSA screening while the older 6-core TRUS had been introduced in the pre-PSA screening era.” And, consider that this is an unsponsored study unlike Dr. Mitchell’s study.

Circling back to Dr. Mitchell’s paper with this background information, today most urologists follow the National Comprehensive Cancer Network’s (NCCN) standard of a 12-core prostate biopsy. Dr. Mitchell’s data covered a transition period when the standard was moving from six to 11 cores in the period she studied (12 today). She may have the right gross mathematical computations for 2005 through 2007, but she ignored the underlying standard of care changes. Then there is the matter of each core in its own vial. Dr. Mitchell dismisses that notion with this statement: “Practice guidelines indicate that it is clinically appropriate to place two cores extracted from the same anatomic region in a single jar, but there is no clinical rationale for placing each core in a separate jar.” In my experience, few urologists and even fewer pathologists agree with her assertion.

In my opinion, Dr. Mitchell’s paper is headline grabbing. But as is the case with much of today’s news, the story behind the headlines is where the truth can usually be found.

Joe Plandowski
President, Lakewood Consulting Group
Lake Forest, Ill.

I read with intense interest Dr. Robboy’s May 2012 column about in-office pathology as it pertains to prostate biopsies. It is interesting that urologists who established in-office pathology laboratories tended to bill for more specimens. However, urologists may choose to do so for reasons unrelated to having a financial incentive. Discrepancies in the number of 88305 charges are primarily attributable to the number of specimen vials submitted. Most urologists now take 12 cores at a time rather than six (mid and lateral for each sextant). Some urologists choose to submit two cores per vial, while others place one core per vial. The latter affords the advantage of more precise mapping of the tumor focus or foci, which facilitates placement of radiation brachytherapy seeds, targeted focal cryotherapy, or watchful waiting if tumor extent is very small. Many urologists and urologic pathologists believe this approach benefits patients, even if it does double the number of 88305s.